telitacicept

GtoPdb is requesting financial support from commercial users. Please see our sustainability page for more information.

Home
Ligands
telitacicept

GtoPdb Ligand ID: 11827

Synonyms: RC-18 | RC18 | Tai'ai®

telitacicept is an approved drug (China (2021))

Compound class: Peptide

Comment: Telitacicept (RC18) is a recombinant fusion protein that combines the ligand-binding domain of the TACI receptor and the Fc component of human IgG. It was designed to inhibit the signalling of B cell BAFF (a.k.a. BLyS; TNFSF13B) and APRIL (TNFSF13) as a disease-modifying mechainism for the treatment of B cell-mediated autoimmune diseases [2-4,6].

No information available.

No information available.

Summary of Clinical Use
Telitacicept's first global approval was issued in China in March 2021 [1]. It was initially indicated as a treatment for patients with active SLE, but this was expanded to include generalised myasthenia gravis (gMG) and rheumatoid arthritis. The US FDA issued orphan drug designation for the treatment of MG in October 2022. The European Medicines Agency (EMA) granted orphan drug designation for this indication in mid-2025. Telitacicept is also under investigation in patients with Sjögren's disease, multiple sclerosis and immunoglobulin-A nephropathy (IgAN; Berger's disease).

Summary of Clinical Use

Telitacicept's first global approval was issued in China in March 2021 [1]. It was initially indicated as a treatment for patients with active SLE, but this was expanded to include generalised myasthenia gravis (gMG) and rheumatoid arthritis. The US FDA issued orphan drug designation for the treatment of MG in October 2022. The European Medicines Agency (EMA) granted orphan drug designation for this indication in mid-2025. Telitacicept is also under investigation in patients with Sjögren's disease, multiple sclerosis and immunoglobulin-A nephropathy (IgAN; Berger's disease).

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT05078710	Telitacicept in Primary APS Patients	Phase 2 Interventional	Peking Union Medical College Hospital
NCT04905212	A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy	Phase 2 Interventional	RemeGen Co., Ltd.
NCT04625153	RC18 in Patients With Relapsing Remitting Multiple Sclerosis：a Phase II Trial	Phase 2 Interventional	RemeGen Co., Ltd.
NCT04082416	Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)	Phase 3 Interventional	RemeGen Co., Ltd.		5
NCT05799287	A Study of Telitacicept in Patients With Primary Immunoglobulin A（IgA） Nephropathy	Phase 3 Interventional	RemeGen Co., Ltd.